ESOXC-ER Efficacy and Safety of an Extended Release (ER) Formulation of Oxcarbazepine (Apydan Extent) in Epileptic Patients

Completed

• Conditions: Epilepsy

• Registration Number: NCT01086501
• Lead Sponsor: Desitin Arzneimittel GmbH

Brief Summary

The aim of the observational study is to investigate the safety of oxcarbazepine extended release (ER) during long-term therapy in epileptic patients. In addition, quality of life parameters should be documented if assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Status Verified: 2010-03
• Study First Submitted: 2010-03-12
• Study First Submitted QC: 2010-03-12
• Study First Posted: 2010-03-15
• Primary Completion: 2011-07
• Study Completion: 2012-10
• Last Update Submitted: 2013-02-28
• Last Update Posted: 2013-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

• patients with focal epileptic seizures with or without secondary generalised tonic-clonic seizures
• mono- or combination therapy
• male and female from the age of 6

Exclusion Criteria

• hypersensitivity to oxcarbazepine MR or one of its excipients

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
tolerability and safety	12 months per patient

Trial Locations

Locations (1)

Dr. Stephan Arnold; 🇩🇪 Munich, Bavaria, Germany